Biofeedback Versus Botox Injection in Treatment of Dyssynergic Defecation (Randomized Controlled Trial)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Improvement of symptoms of constipation for one year follow up
研究概览
简要总结
assessment the Improvement symptoms of obstructed defecation after biofeedback training versus botulinum toxin injection
详细描述
This is a randomized controlled trial including 78 patients diagnosed with obstructed defecation syndrome confirmed by detailed history talking, full clinical examination, anorectal manometry and defecography.
Included patients divided into two equal groups: first group ( biofeedback therapy group) patients recieved biofeedback therapy for six sessions over one month, the second group:( botulinum toxin group) received botulinum toxin injection 100 IU in buborectalis muscle.
The primary outcome is improvement of symptoms after one year
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients of both genders
- •age of 18 years or older
- •fulfillment of the Rome 3 constipation criteria for the past 3 months, symptom onset as a maximum six months prior to diagnosis, patients suffer from prolonged, incomplete and challenging evacuation
排除标准
- •Anismus cases with secondary reason for constipation
- •patients who undergone anorectal surgery Patients with colonic inertia
- •conditions that make biofeedback training impossible
- •cases with primary illness causing constipation as hypothyroidism
研究组 & 干预措施
Biofeedback therapy group
Patients with dyssynergic defecation underwent biofeedback training program in the form of six sessions over one month
干预措施: Biofeedback therapy (Device)
Botox injection group
Participants in this group received 100 international unit of botulinum toxin type A that was injected injections into the puborectalis muscle to alleviate dyssynergic defecation by reducing muscle overactivity and improving coordination.
干预措施: Botulinum Toxin A (Botox ) (Drug)
结局指标
主要结局
Improvement of symptoms of constipation for one year follow up
时间窗: One year
* Follow-up was conducted for about 1 year as regard the improvement in bowel habits. * Patients was asked to fill up a symptom questionnaire (Wexner constipation score with a maximum score of 30 and a minimum of 0) following the therapeutic procedure The wexner constipation score : include 8-item questionnaire about bowel movements frequency, anal pain during evacuation, abdominal pain, incomplete evacuation, time taken for evacuation per attempt, number of attempts for a successful bowel movement in the previous 24 hours, type of assistance for defecation, and duration of constipation. All items are scored from 0 to 4 except for the "type of assistance for defecation," which is scored from 0 to 2.The clinical improvement was chosen when there was decrease in the score.
次要结局
- Improvement of pain for one year follow up(One year)